fluorouracil treatment via colon for colorectal cancer

Conditions: Colorectal Cancer

Summary: fluorouracil (5-fu) is a commonly used drug for colorectal cancer (crc). thermosensitive hydrogel presents a promising carrier for 5-fu to address challenges encountered with traditional administration methods. we propose an integrated approach utilizing colonic transendoscopic enteral tubing to cover the entire colon flexibly, coupled with a thermo-sensitive gel to enhance the adhesion of 5-fu. this clinical trial aims to assess the feasibility, safety, and efficacy of this approach for treating crc.


Eligibility criteria:
inclusion criteria: 1. chinese individuals aged 18 to 75 years, both male and female; 2. histologically confirmed diagnosis of colorectal cancer with measurable primary lesion according to recist 1.1; 3. ecog performance status ≤2; 4. expected survival of more than 3 months; 5. multidisciplinary team consensus that the patient is suitable for adding local chemotherapy to the established tumor treatment regimen; 6. adequate organ function meeting the following criteria: (1) absolute neutrophil count ≥1.5 × 10\^9/l, platelets ≥100 × 10\^9/l, hemoglobin ≥90 g/l; (2) total bilirubin ≤1.5 times the upper limit of normal (patients with biliary drainage via retrograde techniques included); alt and ast ≤5 times the upper limit of normal, and for patients with liver metastases, serum total bilirubin less than or equal to 3 times the upper limit of the normal reference range; (3) creatinine \ 60 ml/min; (4) doppler echocardiography assessment: left ventricular ejection fraction (lvef) ≥50%; 7. women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days before enrollment, and sexually active men or women agree to use appropriate contraception during the trial and for 8 weeks after the last dose of investigational drug; 8. suitable physical condition and personal willingness to undergo colonic transendoscopic enteral tubing; 9. willingness to cooperate with physicians, and agree to regular follow-up visits and examinations as recommended after completion of treatment; 10. agreement to specimen collection and voluntary signing of a written informed consent form. exclusion criteria: 1. uncontrolled cardiovascular diseases, such as congestive heart failure (nyha iii-iv), coronary artery disease, cardiomyopathy, arrhythmias, or hemodynamic instability at enrollment, with a risk of significant events during the treatment period; 2. active severe clinical infections (≥ grade 2 according to nci-ctcae version 5.0), including fungal, viral, or tuberculosis infections within the gastrointestinal tract; 3. coagulation abnormalities with bleeding tendencies (who do not meet the criteria of having a normal inr without the use of anticoagulants within 14 days prior to enrollment). participants receiving anticoagulants or vitamin k antagonists such as warfarin or heparin are excluded unless their international normalized ratio (inr) is ≤1.5, with allowance for low-dose warfarin (1 mg orally once daily) or low-dose aspirin (daily dose not exceeding 100 mg) for prophylaxis; 4. history of immunodeficiency or other acquired or congenital immunodeficiency diseases, or history of organ transplantation; 5. known progressive or actively treated other malignancies requiring intervention, except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ; 6. presence of other serious diseases that would render the subject ineligible for enrollment as determined by the investigator; 7. breastfeeding women; 8. known allergy or intolerance to the investigational drug or its excipients; 9. participation in another drug clinical trial within the past four weeks; 10. lack of legal capacity or restricted legal capacity.

Keywords: fluorouracil transendoscopic enteral tubing thermosensitive hydrogel colorectal cancer